FDA 510(k), K180259, Sterile Hypodermic Needle for Single Use

FDA 510(k), K180259, Sterile Hypodermic Needle for Single Use

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510(K) Number: K180259
Device Name: Sterile Hypodermic Needle for Single Use
Manufacturer: Tina Cai
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 01/30/2018
Decision Date: 05/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

  • Total pages: 612

  • Fully redacted pages: 416

  • Content pages: 196

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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